Chemist - 22857BR - EN

Developing and validating new methods
Overseeing the training on and transfer of methods
Generating all documentation (procedures, protocols, reports) associated with the establishment of analytical methodology
Qualifying laboratory instruments which may include instrument selection, generation and execution of procedures for installation and verification of proper operation and performance of instruments
Troubleshooting test methods and instruments OOS including laboratory investigations.
Assembling ideas, issues and observations into clear explanations and solutions and communicating technical concepts throughout the organization effectively
Working closely with other departments on establishment of appropriate methodology
Understanding and employing laboratory controls
Providing Quality Control support when needed
Job Requirements
Must possess excellent communication and computational skills (college graduate level)
Must generate clear and understandable written correspondence and descriptions
Bachelor's or graduate degree in Chemistry
2-5 years of experience in a medical device or GMP setting
Experience in the development and validation of chromatographic or spectrometric methods
Computer literate in Word, Excel and Outlook
Basic laboratory instrumentation (e.g. pH meter, analytical balance, Karl Fischer, etc.)
High Performance Liquid and Gas Chromatography systems
Spectrophotometers (Raman, FTIR, UV-VIS)
Empower Chromatography Data Software
Laboratory Information Management System (LIMS)
Experience as a laboratory analyst
Hands on experience with developing and validating gas or high performance liquid chromatographic methods (GC or HPLC) using a Life Cycle Validation approach.
Analytical instrument qualification IQ,OQ,PQ
Statistical analysis of Lab Data desired
Experience with current Good Manufacturing Practice (cGMP) or Quality System Regulation (QRS) desired.
Experience with pharmacopeia and/or other industry standards (USP, EP, ASTM, ISO) desired.

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